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DNA TECHNOLOGIES PACIFIC
DNA Technologies Pacific has up-to-date knowledge of a wide range of specific ranges and legal requirements in major markets around the world, and provides technical support services to certify your systems and products. In addition, we provide a series of commissioned and commissioned studies necessary for certification-related clinical trials required for export to the European Union, such as medical devices and cosmetics, as a One-Stop Service.
Emerging European Union medical device certification, MDR and clinical certification are indispensable requirements. If you use services provided by DNA Technologies Pacific, which has long experience in medical device certification and clinical evaluation, you don’t have to worry about the clinical research required by MDR.
The Clinical Trial should be provided with the most competitive manner and get approval by the Ministry of Health from EU Member State for clinical performance which combine the results of the Investigation Study with the Clinical Evaluation Report, PMCF Plan, PMCF Report. We also can help with the Periodic Safety Update Report development needed in order to achieve and maintain your certification.
DNA Technology Pacific conducts clinical work in compliance with the legal requirements of the CRO requested by the Ministry of Health from EU Member State.
DNA TECHNOLOGIES PACIFIC Business
01Safety and efficacy clinical trials for CE certification of medical devices
02PMCF progress on CE certified medical devices
03Support the PMCF Plan, Protocol, and Investigator's Brochure
04Collect health and economic data to obtain approval for reimbursement
05System and product certification technical support